Effect of Preoperative Fiber on Postoperative Bowel Function

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Completed
CT.gov ID
NCT04882995
Collaborator
(none)
84
1
2
24.6
3.4

Study Details

Study Description

Brief Summary

Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. The investigators are conducting this study to determine if participants who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Psyillium fiber
N/A

Detailed Description

Post-operative constipation or delay in return to bowel function is a common concern among patients undergoing pelvic reconstructive surgery. A retrospective study reviewing all patient-initiated telephone calls in the postoperative period after pelvic reconstructive surgery found the most frequent concern among patients to be constipation. Moreover, prevention of constipation may help minimize unnecessary pressure and strain on the pelvic floor during post-operative recovery.

There are various strategies for managing post-operative constipation which typically involve medications including stool softeners, laxatives, or stool bulking agents. Several studies have examined the use of these postoperative regimens and have found a shortened time to first bowel movement (BM) with a combination of these medications when compared to placebo.Despite the use of these regimens, most patients do not have their first BM until the second or third postoperative day and this can result in significant distress, discomfort, and fecal impaction.

Postoperative constipation is a multifactorial process and an alternative approach involves consideration of the preoperative period. Preoperative defecation patterns can be a factor in the development of postoperative constipation. We are not aware of any studies looking at the effect of preoperative intervention on postoperative bowel function, particularly the use of preoperative fiber supplementation.

Psyllium fiber is a dietary supplement and stool bulking agent that stimulates peristalsis and improves bowel evacuation. The Western diet is low in fiber and women with pelvic organ prolapse have been found to have lower dietary intake of fiber when compared to controls.8 The primary objective of this study is to evaluate whether the use of preoperative psyllium fiber intake reduces time to first bowel movement after pelvic reconstructive surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Preoperative Fiber on Postoperative Bowel Function
Actual Study Start Date :
May 13, 2019
Actual Primary Completion Date :
May 28, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention - Received fiber

Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.

Dietary Supplement: Psyillium fiber
Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery

No Intervention: Control - Did not receive fiber

Participants did not take any preoperative fiber.

Outcome Measures

Primary Outcome Measures

  1. Time to First Bowel Movement After Surgery [Within 7 days]

    Date and time of first bowel movement captured via postoperative bowel diary

Secondary Outcome Measures

  1. Pain Associated With First Bowel Movement After Surgery [Within 7 days]

    Pain captured with visual analog scale with 0 being no pain and 10 being worst pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Women undergoing prolapse repair with or without hysterectomy on the University of Massachusetts urogynecology service
Exclusion Criteria:
  • Unable to provide consent

  • Under 18 years of age

  • Pregnant women

  • Prisoners

  • As our validated questionnaires are only available in English, we are unable to offer study participation to Non-English speaking subjects

  • Because these conditions intrinsically affect bowel function, women with the following will be excluded: history of inflammatory bowel disease, colorectal cancer, rectovaginal fistula, sigmoid resection or rectal surgery

  • Because the use of motility agents can affect bowel function and stool transit, women using motility agents such as linaclotide will be excluded.

  • Concurrent bowel surgery due to potential effect on the surgical field

  • Concurrent anal sphincteroplasty due to potential effect on the surgical field

  • Insulin-dependent diabetes mellitus with known gastroparesis as this would affect transit of fiber supplement

  • Patients with a history of phenylketonuria as the psyllium fiber supplement we will be using contains phenylalanine

  • History of placement of sacral neuromodulating device for indication of fecal incontinence, as this would affect bowel function

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01605

Sponsors and Collaborators

  • University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Deepali Maheshwari, DO, MPH, UMass Chan Medical School

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Deepali Maheshwari, Clinical Instructor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT04882995
Other Study ID Numbers:
  • H00017494
First Posted:
May 12, 2021
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Deepali Maheshwari, Clinical Instructor, University of Massachusetts, Worcester
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Intervention - Received Fiber Control - Did Not Receive Fiber
Arm/Group Description Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. Participants did not take any preoperative fiber.
Period Title: Overall Study
STARTED 41 43
COMPLETED 35 36
NOT COMPLETED 6 7

Baseline Characteristics

Arm/Group Title Intervention - Received Fiber Control - Did Not Receive Fiber Total
Arm/Group Description Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. Participants did not take any preoperative fiber. Total of all reporting groups
Overall Participants 35 36 71
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
60.7
(11.9)
60
(10.3)
60.3
(11.0)
Sex: Female, Male (Count of Participants)
Female
35
100%
36
100%
71
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
5.7%
3
8.3%
5
7%
Not Hispanic or Latino
33
94.3%
33
91.7%
66
93%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
2.9%
2
5.6%
3
4.2%
White
32
91.4%
31
86.1%
63
88.7%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
2
5.7%
3
8.3%
5
7%
PAC-SYM (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]
0.5
0.3
0.3

Outcome Measures

1. Primary Outcome
Title Time to First Bowel Movement After Surgery
Description Date and time of first bowel movement captured via postoperative bowel diary
Time Frame Within 7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention - Received Fiber Control - Did Not Receive Fiber
Arm/Group Description Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. Participants did not take any preoperative fiber.
Measure Participants 35 36
Mean (Standard Deviation) [hours]
66.5
(22.7)
68.3
(25)
2. Secondary Outcome
Title Pain Associated With First Bowel Movement After Surgery
Description Pain captured with visual analog scale with 0 being no pain and 10 being worst pain
Time Frame Within 7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention - Received Fiber Control - Did Not Receive Fiber
Arm/Group Description Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. Participants did not take any preoperative fiber.
Measure Participants 35 36
Median (Full Range) [score on a scale]
2.0
2.0

Adverse Events

Time Frame 2 weeks
Adverse Event Reporting Description
Arm/Group Title Intervention - Received Fiber Control - Did Not Receive Fiber
Arm/Group Description Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. Participants did not take any preoperative fiber.
All Cause Mortality
Intervention - Received Fiber Control - Did Not Receive Fiber
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/35 (0%) 0/36 (0%)
Serious Adverse Events
Intervention - Received Fiber Control - Did Not Receive Fiber
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/35 (0%) 0/36 (0%)
Other (Not Including Serious) Adverse Events
Intervention - Received Fiber Control - Did Not Receive Fiber
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/35 (0%) 0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Deepali Maheshwari
Organization UMass Chan Medical School
Phone 4137948764
Email deepali.mahesh@gmail.com
Responsible Party:
Deepali Maheshwari, Clinical Instructor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT04882995
Other Study ID Numbers:
  • H00017494
First Posted:
May 12, 2021
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022